Federal officials said that the United States should resume use of the Johnson & Johnson COVID-19 vaccine, which has been on pause since April 13th. The company updated the fact sheets about the vaccine for doctors and patients to include information about the risks of clots.
Vaccinations with the Johnson & Johnson shot could start back up as soon as tomorrow morning, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a press briefing.
The decision to reinstate the J&J vaccine follows the recommendation of an independent CDC advisory group earlier today. The committee stressed that officials should make people aware of the risk of rare blood clots, which appear most often in women under 50.
The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) had instituted the pause after receiving reports of unusual blood clots in a handful of people who received the shot. As of Friday, officials had 15 reports of women developing rare blood clots called cerebral venous sinus thrombosis after receiving the vaccine. Other unconfirmed reports are under investigation. Around 8 million people have received the shot in the US, including 4 million women.
The clots, which form in the brain, appeared in combination with low levels of platelets, a type of blood cell involved with clotting. The federal agencies recommended the pause so that experts could gather more information about the clots and so they could give doctors information on how to recognize and treat the condition — in this case, the standard blood clot treatments could make things worse.
Many states were using the one-shot, easy-to-store Johnson & Johnson vaccine for people who are homebound, people experiencing homelessness, and other underserved groups. While many vaccination sites switched people scheduled for the Johnson & Johnson vaccine to the Moderna or Pfizer / BioNTech shots instead, some people in vulnerable groups weren’t able to get vaccinated because of the halt.
The CDC will keep monitoring cases of the clotting condition in people who get the Johnson & Johnson vaccine.